Ace Color Test

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K833933 ↗

FDA Product Code

KQN

Device Class

Class II

Regulation

21 CFR Part 862.1090

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K855205 Active Cleared 5 Feb 1986

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  FDA 510(k) K822736 Active Cleared 3 Dec 1982

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• Chang Medium

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  FDA 510(k) K812820 Active Cleared 10 Nov 1981

See all devices from Hana Biologics, Inc. →

• What is the ACE COLOR TEST used for?

  The ACE COLOR TEST is a radioassay device used for clinical chemistry testing to measure angiotensin converting enzyme levels, providing quantitative results for laboratory diagnostic purposes.

• Is the ACE COLOR TEST a single-use device?

  Yes, the ACE COLOR TEST is supplied as a single-use device and requires appropriate storage conditions to maintain its integrity and accuracy for clinical testing.

• What is the regulatory status of the ACE COLOR TEST?

  The ACE COLOR TEST is authorized under FDA 510K clearance with product code KQN and device class 2, intended for use in clinical chemistry laboratories.

• What is the manufacturer of the ACE COLOR TEST?

  The ACE COLOR TEST is manufactured by Hana Biologics, Inc., located in McHenry, IL, with the device receiving FDA clearance in 1984.